Major Deficiencies in Design; Funding of Clinical Trials Affects Future of Scientific Innovation

... Report Issued to Improve Policies Affecting How Human Studies Are...WASHINGTON April 1 2008 -- At the same time...The result of the multi-year EDICT (Eliminating Disparities in Clinica...Among the deficiencies cited are the exclusion or under-representation...

WASHINGTON, April 1, 2008 /PRNewswire-USNewswire/ -- At the same time
that medical science is making possible new therapies for treating AIDS,
cancer, and other once fatal diseases, a new report finds major
shortcomings in the way clinical trials are designed, carried out and
funded in the U.S. with serious implications for the outcomes of medical
research studies.

The result of the multi-year EDICT (Eliminating Disparities in Clinical
Trials) Initiative conducted by the Chronic Disease Prevention and Control
Research Center (CDPCRC) at Baylor College of Medicine in Houston and the
Intercultural Cancer Council (ICC), the report provides an in-depth
assessment of the state of clinical trials in the U.S. and offers a
nine-step action plan for improving the relevant policies of public,
private and non-profit sponsors of clinical trials that affect how human
studies are conducted.

Among the deficiencies cited are the exclusion or under-representation
of women, older people and minorities in the vast majority of human
research studies; insufficient training in disparities for members of
institutional review boards (IRBs), who by law, must review the protocols
for all clinical studies; and the duplication of effort in the diseases
studied by government and private industry, resulting in insufficient
attention and resources for diseases where there are significant
disparities in outcomes and high case fatality rates.

Because identifying potential differences among groups treated with a
therapeutic regimen is an important goal of human studies, the EDICT review
singles out the under-representation of women, older people, minorities,
disabled persons, and rural populations in clinical trials as the problem
requiring immediate attention and change at a systemic level. Looking
specifically at cancer clinical trials where a lot has been published about
the composition of clinical trials, the report reveals that only 25 percent
of those taking part in cancer studies in 2003 were over 65 years of age.
Older Americans are also routinely left out of clinical trials studying
diseases associated with aging, such as Alzheimer's disease, arthritis, and
incontinence.

At the same time, the report finds that the biomedical research
community has been unsuccessful in resolving the under-representation of
women, older adults, and racial and ethnic minorities in clinical research
studies, despite many efforts to improve the performance in this area. One
study cited in the report that examined the composition of clinical trials
testing new cancer drugs between 1995-1999 found less than 10 percent of
the patients studied collectively represented African Americans,
Asian/Pacific Islanders, Hispanics and Native Americans.

"Although disparities in clinical trials has been discussed and debated
extensively, this problem has generally been under-addressed and, as a
result, has received little direct, systematic, or sustained intervention,"
said Armin D. Weinberg, Ph.D., Director of Baylor College of Medicine's
Chronic Disease Prevention and Control Research Center and EDICT's
Principal Investigator. "This report is intended as a nationwide call to
action and is provided as a blueprint for removing the barriers to clinical
trial participation, which is a critical step to improving the health
status of all Americans."

More than an issue of fairness, the EDICT report associates better
designed clinical research studies with the increased ability of scientists
to catalog and understand the influence of genetic and non-genetic factors
on individual and group responses to treatments, now possible as a result
of the successful sequencing of the human genome. Findings from the large
amount of genetic data generated to date show that more than 90 percent of
the observed genetic variations occur within rather than between groups.
This underscores the fact that ethnicity -- which incorporates multiple
variables including genetics, economic, social, dietary, religious, and
linguistic background -- has biomedical consequences when studying health
outcomes.

Accordingly, the EDICT report identifies a number of behavioral,
social, economic, medical, and policy-related factors that must be
addressed if the biomedical research community -- government researchers,
academic centers and other non-profit sponsors, and industry scientists --
is to meet the complex healthcare needs of an ever more diverse U.S.
population. Among the factors singled out for corrective action are:

-- Strict inclusion or exclusion eligibility criteria that excludes
patients who have co-morbidities, those who speak languages other than
English, and subjects over a certain age;

-- Lengthy and complex consent forms and other clinical trials
materials that are difficult to read and are printed only in English;

-- Vague information about how Medicare, Medicaid and private health
insurers reimburse for the routine costs associated with being in a
clinical trial;

-- Insufficient training for institutional review boards (IRBs), which
results in the systematic approval of research protocols that do not
provide for inclusion of underrepresented populations;

-- Divergent federal policies about the level of participation of
racial and ethnic groups in government-sponsored clinical trials; and

-- A significant duplication of effort in the diseases studied by
government and private industry sponsors, resulting in insufficient
attention and resources for diseases, such as liver and kidney cancers,
where there are significant disparities in outcomes and high-case fatality
rates.

The report, prepared through a collaborative process involving more
than 300 representatives of public, private and non-profit stakeholders who
worked in teams over several years, finds that extensive barriers to
clinical trial participation exist at every level, requiring immediate and
longer-term policy change. Towards this end, the EDICT report calls for
implementation of a series of practical and realizable policy solutions to
clinical trials disparities in the following areas:

1. Implement regulatory changes to improve the way research trials are
designed and conducted. The report calls on the Food and Drug
Administration (FDA) to harmonize its policies so they are consistent with
the NIH Revitalization Act of 1993, thereby mandating to require
appropriate inclusion of under-represented populations in all clinical
trials conducted to bring new drugs and devices to the market. EDICT team
also advocates expanding the application of the federal government's CLAS
(Culturally and Linguistically Appropriate Services) standards in clinical
trials as a necessary step to improve the way government-sponsored research
is designed and conducted.

2. Increase the collaboration between government and industry in the
design and implementation of clinical research. Because nearly 75 percent
of the funding for clinical trials comes from industry sponsors, new
initiatives that attract more women, older people, minorities, and rural
populations into research studies are needed to ensure the generalization
of results. This will entail creating new regulatory incentives for
pharmaceutical industry trials to include underrepresented populations, as
well as imposing penalties for non-compliance with federal policy on
appropriate inclusion.

3. Foster community involvement in clinical trials. Today, community
organizations are usually left out of the clinical trials process,
resulting in increased costs and additional resources for investigators to
conduct population-relevant clinical trials and secure enrollment into
these trials. Towards this end, the EDICT team recommends that
investigators build a detailed plan for community engagement into the
research protocol that includes demonstrated methods and measures for
working with community organizations and institutions.

4. Implement new policies so that peer-reviewed medical/science
journals addressthe issue of the representation of trial subjects in
clinical research studies. Although peer-reviewed medical/science journals
have addressed significant issues where increased attention by the
scientific community is warranted, the discussion of diversity, inclusion
and representation in clinical trials has been missing from published
studies. To change this situation, the EDICT team is calling on two chief
editorial organizations for biomedical publications -- the International
Committee of Medical Journal Editors (ICJME) and the World Association of
Medical Editors (WAME) -- to adopt standards that require investigators to
include in their manuscripts an analysis of how the subject population's
demographics correspond to those of the population that bears the greatest
disease burden.

5. Invest in specialized training for Institutional Review Boards.
Although the mission of institutional review boards (IRBs) is to safeguard
the rights, safety, and well being of all human research participants, IRB
members often lack the training needed to recognize disparities, and thus
regularly approve research protocols that do not provide for inclusion of
under-represented populations. Accordingly, an important priority is to
work through the HHS Office of Human Research Protections (OHRP), which
oversees the regulation of IRBs, and the Association for the Accreditation
of Human Protections Programs (AAHRPP) to add specific requirements that
IRBs receive training in healthcare disparities.

6. Reallocate research funding to avoid duplication and address
disparities. The report reveals a major duplication of research efforts in
some disease categories and insufficient attention and resources for
diseases, such as liver and kidney cancers, where there are significant
disparities in outcomes and high case fatality rates. Addressing this
problem will require an honest broker to access areas of duplicative
research, which is why EDICT recommends that the Institute of Medicine
conduct a new study that will recommend strategies for eliminating
duplication and promoting coordination. Based on this assessment, Congress
will be able to ensure that federal research funding complements private
sector funding and gives priority to diseases with the greatest disparities
and the highest case fatality rates.

7. Enhance public education about clinical trials. Lack of awareness
about clinical trials, fear or mistrust of medical research, and the
complexity of consent forms and other clinical trials materials are major
barriers to patient accrual. Accordingly, the report calls for the
widespread development and implementation of culturally appropriate
recruitment and retention plans with an additional focus on community
education provided in appropriate languages for non-English and
limited-English speaking populations.

8. Implement participant navigation as a critical element of the
clinical trials process. Modeled after the "navigator" program created at
Harlem Hospital, patient navigation is a new tool that helps patients keep
their appointments and solves their non-medical problems. Because of its
potential to retain patients in medical research studies, an analogous
process termed "participant navigation" should become the accepted standard
of practice for institutions conducting clinical trials.

9. Assure insurance coverage of the costs associated with clinical
trials. The costs associated with participating in a clinical trial are a
concern to all patients and have remained a major barrier to patient
accrual. Addressing this problem will require actions by both policy makers
and the business community to identify and close any existing gaps and to
produce and disseminate easy-to-understand information about what the
insurance program actually covers.

Eliminating Disparities in Clinical Trials (EDICT) is a four-year
initiative, funded with an unrestricted educational grant from Genentech,
Inc. and conducted jointly by the Chronic Disease Prevention and Control
Research Center at Baylor College of Medicine and the Intercultural Cancer
Council. The goal of the EDICT project is to review relevant policies of
public, private and non-profit sponsors of clinical trials to identify
problems and prescribe solutions.

The report issued today will be distributed widely to health policy
makers, regulators, the public health community, clinicians, the
pharmaceutical industry, and patient advocates with the goal of
implementing a series of practical and realizable policy solutions to
clinical trials disparities at the federal, state and institutional levels
in the public, private and non-profit sectors.

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